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Type: Journal article
Title: Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer
Author: Peeters, M.
Price, T.
Cervantes, A.
Sobrero, A.
Ducreux, M.
Hotko, Y.
Andre, T.
Chan, E.
Lordick, F.
Punt, C.
Strickland, A.
Wilson, G.
Ciuleanu, T.
Roman, L.
Van Cutsem, E.
Tzekova, V.
Collins, S.
Oliner, K.
Rong, A.
Gansert, J.
Citation: Journal of Clinical Oncology, 2010; 28(31):4706-4713
Publisher: Amer Soc Clinical Oncology
Issue Date: 2010
ISSN: 0732-183X
Statement of
Marc Peeters, Timothy Jay Price, Andrés Cervantes, Alberto F. Sobrero, Michel Ducreux, Yevhen Hotko, Thierry André, Emily Chan, Florian Lordick, Cornelis J.A. Punt, Andrew H. Strickland, Gregory Wilson, Tudor-Eliade Ciuleanu, Laslo Roman, Eric Van Cutsem, Valentina Tzekova, Simon Collins, Kelly S. Oliner, Alan Rong and Jennifer Gansert
Abstract: Purpose Panitumumab is a fully human anti–epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status. Patients and Methods Patients with mCRC, one prior chemotherapy regimen for mCRC, Eastern Cooperative Oncology Group performance status 0 to 2, and available tumor tissue for biomarker testing were randomly assigned 1:1 to panitumumab 6.0 mg/kg plus FOLFIRI versus FOLFIRI every 2 weeks. The coprimary end points of PFS and overall survival (OS) were independently tested and prospectively analyzed by KRAS status. Results From June 2006 to March 2008, 1,186 patients were randomly assigned 1:1 and received treatment. KRAS status was available for 91% of patients: 597 (55%) with wild-type (WT) KRAS tumors, and 486 (45%) with mutant (MT) KRAS tumors. In the WT KRAS subpopulation, when panitumumab was added to chemotherapy, a significant improvement in PFS was observed (hazard ratio [HR] = 0.73; 95% CI, 0.59 to 0.90; P = .004); median PFS was 5.9 months for panitumumab-FOLFIRI versus 3.9 months for FOLFIRI. A nonsignificant trend toward increased OS was observed; median OS was 14.5 months versus 12.5 months, respectively (HR = 0.85, 95% CI, 0.70 to 1.04; P = .12); response rate was improved to 35% versus 10% with the addition of panitumumab. In patients with MT KRAS, there was no difference in efficacy. Adverse event rates were generally comparable across arms with the exception of known toxicities associated with anti-EGFR therapy. Conclusion Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.
Keywords: Humans
Colorectal Neoplasms
ras Proteins
Proto-Oncogene Proteins
Antineoplastic Combined Chemotherapy Protocols
Antibodies, Monoclonal
Neoplasm Staging
Disease-Free Survival
Treatment Outcome
Chemotherapy, Adjuvant
Infusions, Intravenous
Drug Administration Schedule
Prospective Studies
Predictive Value of Tests
Gene Expression Regulation, Neoplastic
Aged, 80 and over
Middle Aged
Proto-Oncogene Proteins p21(ras)
Kaplan-Meier Estimate
ErbB Receptors
Biomarkers, Tumor
Rights: © 2010 by American Society of Clinical Oncology
DOI: 10.1200/JCO.2009.27.6055
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